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FDA 510(k)

E1000 Dx Digital Pathology Solution

K-Number: K241717 · 2025-02-28

ApplicantShandon Diagnostics Limited
Decision Date2025-02-28
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

E1000 Dx Digital Pathology Solution is a medical device manufactured by Shandon Diagnostics Limited. It received FDA 510(k) clearance on 2025-02-28 under approval number K241717. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E1000 Dx Digital Pathology Solution?

E1000 Dx Digital Pathology Solution is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Shandon Diagnostics Limited. The 510(k) number is K241717.

When was E1000 Dx Digital Pathology Solution approved by the FDA?

E1000 Dx Digital Pathology Solution received FDA 510(k) clearance on 2025-02-28, under approval number K241717.

What company makes E1000 Dx Digital Pathology Solution?

E1000 Dx Digital Pathology Solution is manufactured by Shandon Diagnostics Limited.

What is the FDA product code for E1000 Dx Digital Pathology Solution?

The FDA product code for E1000 Dx Digital Pathology Solution is PSY.

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Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 41437380 Applications of artificial intelligence in non-small cell lung cancer: from precision diagnosis to personalized prognosis and therapy. Journal of translational medicine (2025) PMID: 40890852 Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome. Trials (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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